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SOMNOmedics ABPMpro User Manual

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  • Page 1 User Manual ABPMpro...
  • Page 2 D-97236 Randersacker Tel.: (+49) 931 / 35 90 94 - 0 Fax: (+49) 931 / 35 90 94 – 49 E-Mail: info@somnomedics.de Internet: www.somnomedics.de Rev. 1 10.03.2023 All proper names marked with ™ or ® are copyright protected by SOMNOmedics...
  • Page 3 Installation of the ABPMpro software ..................15 Update from the software ......................20 Operating the ABPMpro ......................22 Initialisation ..........................22 Application of the ABPMpro and its sensors ................25 5.2.1 Applying the basic device ....................25 5.2.2 Applying the external ECG sensor..................26 5.2.3...
  • Page 4 Technical data ABPMpro ......................50 Life time ............................ 50 Operating, storage and transport conditions ................51 EMC information ........................51 Malfunction ..........................53 Warranty ........................... 53 Disposal of application parts and/or the ABPMpro ..............53 Accessories and spare parts ....................54 Notes ............................55...

  • Page 5: Meaning Of Symbols In This Manual

    1 Introduction Thank you for purchasing this product from SOMNOmedics. Please read the following instruction manual carefully before installing and using the device. Suggestions to improve the functional characteristics of the device and the instruction for use, we accept at any time.
  • Page 6 2 About the ABPMpro The ABPMpro consists of the following hardware: • ABPMpro recorder with integrated accelerometer and position sensor; • Brachial blood pressure cuff (3 sizes available to fit the patient's arm size) with integrated 1- channel ECG sensor;...
  • Page 7 Please ensure, immediately after receipt of the device, that the device is not damaged and that the accessories ordered are included, according to the delivery note. The model name on the product label (at the back of the device) should be ABPMpro and the reference number ABP050. Picture 2-4: Product label ABPMpro...
  • Page 8 Specification of the internal operating voltage and power consumption Specification of the external operating voltage and power consumption Picture 2-5: Product label cuff Product label Cuff ABPMpro – Information, symbols, icons and classification on this label Manufacturer printed right from this symbol Reference number...
  • Page 9 Picture 2-6: Symbols on power supply ABPMpro Important symbols on power supply ABPMpro model GTM46101-1005-USB GlobTek Manufacturer printed right from this symbol The power supply is intended for indoor use only Used electrical appliances must not be disposed of with household waste...

  • Page 10: Intended Use

    ECG device. 2.4.2 Users and context of use The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: •...
  • Page 11 2.4.3 Patients The ABPMpro and its accessories may only be used on patients aged 12 years and older. It may only be used on intact skin. 2.4.4 Indications The device enables long-term measurements of blood pressure and ECG of up to 24 h duration.
  • Page 12 The system is intended exclusively for diagnostic applications or as a source of data for making a diagnosis. It is not intended for use in life-support and monitoring systems. The use of the ABPMpro and its accessories is excluded for patients requiring monitoring and intensive care.
  • Page 13 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ABPMpro, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 14 1 to 1.5 minute between two consecutive measurements, to allow the blood circulation in the arm to recover. In case external devices are connected to the same limb as the ABPMpro system and are placed underneath or below the cuff this could lead to temporarily loss of function or artefact afflicted signals.

  • Page 15: System Requirements

    Use appropriate antivirus software and a firewall to protect your system from malware. 4.2 Installation of the ABPMpro software Please check the above-mentioned system requirements for the ABPMpro software. Only use an installation file that comes from a trusted source, like delivered along with the system, provided by our distributor or downloaded from our website (customer login).
  • Page 16 Confirm the welcome message by pressing Picture 4-2: ABPMpro software installation Confirm the default installation folder or adapt the folder by clicking “Browse…”, please DO NOT install the software in the Program Files Folder of Windows as this could lead to the software not working correctly.
  • Page 17 Confirm the new installation by pressing Picture 4-4: ABPMpro software installation Select the components that have to be installed and press Picture 4-5: ABPMpro software installation -17-...
  • Page 18 To start the actual installation, confirm this screen by pressing Picture 4-6: ABPMpro software installation The installation will now run. Picture 4-7: ABPMpro software installation -18-...
  • Page 19 After the installation is ready the question of installing the USB drive will show up. Please check the box, (shown in the image below) highlighted with a red square. Then confirm with Picture 4-8: ABPMpro software installation The installation of the USB driver will now start automatically.
  • Page 20 If you would like to update the software, please install the software in the same folder as the current version has been installed. You will be asked if you are sure, confirm with “Yes”. Picture 4-10: Update ABPMpro software Instead of new installation the following selection screen will appear, please select the desired option and confirm with .
  • Page 21 Select which parts should be updated and confirm with Picture 4-12: User defined update ABPMpro software No matter which option was selected, now follow the steps that are equal equivalent to the intial installation. -21-...
  • Page 22 2. Start a measurement on the device using the last programmed protocol. Initialisation Option 1 – using the PC Connect the ABPMpro to the PC using the USB cable that has been supplied with the system and the virtual docking station should pop-up, as shown underneath.
  • Page 23 Picture 5-2: Prepare new recording -23-...
  • Page 24 The minimum value is 130mmHg. In the automatic mode the systolic blood pressure is detected and ABPMpro will not pump unnecessary high. Display •...
  • Page 25 Picture 5-3: Apply the ABPMpro Slide the ABPMpro onto the docking station securely until you hear a click. Only then the device is properly attached. If you do not have an external ECG sensor attached and would like to use the internal ECG sensor, make sure that both metal studs have skin contact.
  • Page 26 5.2.2 Applying the external ECG sensor Make sure the skin is cleaned properly with an isopropanol where the ECG electrodes will be attached to the skin. In the case of the patient has a lot of chest hair on the places where the electrodes should be attached, we recommend that this is shaved.
  • Page 27 5.2.3 Applying the pleth sensor (ABP510 and ABP510R) As a reference to apply the pleth sensor correctly you will find a green stripe on the cuff, which is when the cuff is properly attached, at the back of the arm. The pleth sensor should be attached underneath the cuff at this point.

  • Page 28: Starting The Measurement

    5.3 Starting the measurement 5.3.1 Precautions before starting a measurement Make sure to follow underneath measurement procedure for the first measurement Conditions • Quiet room with comfortable temperature; • No smoking, caffeine, food or exercise for 30 min before the measurement; •...
  • Page 29 If during initialisation the wrong cuff size was programmed it can be adapted on the device, please press the (arrow) button to move the cursor to the capital S, M or L. Use the (on) button to change the current selected cuff size. Use the arrow button to get back to the start recording. In case the device noticed a different cuff size during the initial measurement, there will be an error message “cuff mismatch”...
  • Page 30 Picture 5-9: Display after first successful measurement If you want to cancel the recording use the (arrow) button to move the cursor to “Cancel“. Confirm with (on) button to cancel the recording. You have to confirm this one more time. Then the measurement will be cancelled.
  • Page 31 5.4 Transferring the data to the PC To transfer the data from the ABPMpro, release the ABPMpro from the cuff. Make sure the device and ECG sensor are no longer connected to the patient. Now connect the ABPMpro using the USB cable to the PC.
  • Page 32 Picture 5-13: Download data to PC -32-...
  • Page 33 To open the software please click on the icon shown underneath. This should be on your desktop. Picture 6-1: Desktop icon ABPMpro software 6.1 Opening a measurement After opening the ABPMpro Software, the patient list will appear. Please select the measurement you would like to open. Picture 6-2: Opening a measurement If the measurement has not yet beenanalysed, it will now be analysed automatically.
  • Page 34 Picture 6-3: First view on a measurement -34-...
  • Page 35 6.2 Adapting and analysing a measurement Please be aware that blood pressure readings can be affected by the measurement site, position of the patient (standing, sitting, lying down), exercise or the patient’s physiologic condition. How to exclude a measurement is explained at point four in this chapter. 1.
  • Page 36 If both inflation and deflation was selected in the initialisation, then you can select according to which one you want to use to analyse the measurement: Inflation, Deflation or both. The BP-Artefact diff. Is the minimum value that needs to be between the systolic and diastolic blood pressure.
  • Page 37 5. Measurement overview window In the overview window, day and nighttime are marked with the sun and moon respectively. The moon represents the time in bed (TIB). This time is automatically adjusted based on the body position and the activity. In case you would like to adapt it to a different timing. Make sure the measurement is in edit mode: Menu “Mode“...
  • Page 38 Picture 6-9: Measurement overview cuff-based blood pressure measurement -38-...
  • Page 39 Picture 6-10: Measurement overview continuous blood pressure measurement -39-...
  • Page 40 Explanation of what we see in two above shown overviews: Daytime periods B. Time in bed (TIB) period(s) marked by the lights off and on markers C. Systolic (red) and diastolic (Lilac) limits for hypertension according to the set guidelines D.

  • Page 41: Generate A Report

    6.3 Generate a report To generate a report, go to the Menu: Report. The report will be generated. This can be exported, by going though Menu: File > Export, in the following formats: pdf, rtf, docx and xlsx. Underneath is a sample of the first page of the report, the graph and table displays only the cuff-based blood pressure measurement values.
  • Page 42 The second page summarizes the continuous blood pressure values. Picture 6-12: Second page report – continuous blood pressure measurement -42-...
  • Page 43 Here the cuff based blood pressure values are plotted for the time intervals. Blueish background corresponds to the TIB. Picture 6-13: Third page report – cuff-based blood pressure table -43-...

  • Page 44: Ecg Analysis

    Cardiomatics. The data must be exported from our measurement to import it in the external ECG analysis software. Follow the steps displayed belowfor the export of the ECG signal from the ABPMpro Software, for the import in the external software we refer to the manual of the external software.
  • Page 45 The calculation of the heart rate is based on the following algorithm „QRSDet“ from Hamilton, Tompkins, W. J., "Quantitative investigation of QRS detection rules using the MIT/BIH arrhythmia database", IEEE Trans. Biomed. Eng., BME-33, pp. 1158-1165, 1987, in der Version 12/04/2000. The heart rate is calculated from the distance between two R-peaks.
  • Page 46 7 Error messages and problem solving Error description Possible root cause Check for root cause Intialisation / Transfer Virtual docking station Virtual docking station Go to the installation folder > bin64 > does not show up was closed ABPMDockingStation.exe After the restart it should work again Virtual docking station Wrong USB cable Please check that you use the original USB...
  • Page 47 Movement Please do not move during the cuff Keep arm still measurement Failure messages Error code Message Possible actions Sensor defect Please contact your distributor Please call service External ECG defect Please contact your distributor Please call service Pleth Please contact your distributor Please call service Internal ECG Make sure the cuff is applied tight,...

  • Page 48: Maintenance And Disinfection

    8 Maintenance and disinfection 8.1 Maintenance The ABPMpro system requires maintenance every 2 years. The maintenance includes, calibration, internal battery exchange, examination for damage, a test for proper functioning and in case needed, a firmware update. Maintenance can only be performed by the manufacturer or a certified professional by the manufacturer.

  • Page 49: Essential Requirements

    It takes approximately 2.5 h to charge a completely discharged battery. The battery is fully charged when the battery at the ABPMpro display is completely filled. To charge the ABPMpro use the supplied USB cable to either connect it to the PC or the power supply to charge the system without a PC.
  • Page 50 2,4 A Protection class Life time The assumed product life for the ABPMpro is 7 years. We therefore strongly recommend that you follow the recommended maintenance intervals of 2 years. Otherwise, we cannot guarantee the expected product life cycle. Prematurely aged or defective sensors and connecting cables must be replaced.

  • Page 51: Operating, Storage And Transport Conditions

    This information is excerpted from European standards for electrical medical devices. They must be observed when installing and combining SOMNOmedics devices with products from other manufacturers. In case of ambiguity, the complete standard should be consulted. Guidance and manufacturer’s declaration — electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below.
  • Page 52 450 MHz FM ± 5 kHz @ 1 kHz, 28 external antennas) should be used no closer than 30 IEC 61000-4-3 cm (12 inches) to any part of the ABPMpro, including 710 MHz PM @ 217 Hz, 9 V/m cables specified by the manufacturer. Otherwise,...

  • Page 53: Warranty

    (consider the safety instructions) The warranty only refers to the main device ABPMpro and includes a period of 24 months. If you use accessories which are not authorised by SOMNOmedics and it comes to service provision, this will be invoiced.

  • Page 54: Accessories And Spare Parts

    9.8 Accessories and spare parts Part number Description Cable length Part of part number ABP050 ABPMpro ● ABP500 Cuff - Small ○ ABP501 Cuff – Medium ● ABP502 Cuff - Large ○ ABP530 Power supply ● BT-K0000502 USB-charging cable 150 cm ●...
  • Page 55 9.9 Notes -55-...

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